The effect of tizanidine on spasticity in patients with diffuse axonal injury

Investigating the effectiveness of Tizanidine in improving spasticity in patients with diffuse axonal injury related to brain injury: a randomized double-blind trial

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20190810044500N27

Enrollment

Registered

2024-10-03

Start date

2024-10-22

Completion date

Unknown

Last updated

2025-01-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Spasticity in patients with diffuse axonal injury. Disorders of multiple cranial nerves

Interventions

Intervention 1: Intervention group: Patients in the intervention group will use tizanidine 4 mg tablets twice a day (Ector company) during their stay in the intensive care unit. Intervention 2: Contro

Eligibility

Sex/Gender

All

Age

15 Years to 60 Years

Inclusion criteria

Inclusion criteria: Patients aged 15 to 60 years Patients diagnosed with diffuse axonal damage based on neurosurgery expert diagnosis and imaging evidence have the ability to receive medication orally or through a nasogastric tube. Do not have chronic liver and kidney disease

Exclusion criteria

Exclusion criteria: The presence of chronic kidney and liver diseases Lack of informed consent by the patient's first degree relatives spinal cord injury , Penetrating head injury , Previous traumatic brain injury Kidney and liver failure pregnancy History of allergy to tizanidine Patients who change their treatment plan while studying, for example, need surgery.

Design outcomes

Primary

Measure	Time frame
The Modified Ashworth Scale (MAS). Timepoint: Days 1, 3, 6, 9, 12 and 15 after head trauma. Method of measurement: Check muscle tone.	—

Secondary

Measure	Time frame
The Disability Rating Scale. Timepoint: 0, 1, 3 and 7 days and discharge day. Method of measurement: DRS rates eight subscales; In fact, it measures the level of consciousness, cognitive independence in self-care, employability and the need for supervision and subscale ratings, and finally gives a total score to their sum. These categories are: no disability (score 0), mild (1), partial (2-3), moderate (4-6), moderately severe (7-11), severe (12-16), very severe (17-21), vegetative state (22-24), and severe vegetative state (25-29) and death (30). DRS is scored by a neurosurgeon.	—

Measure

Time frame

The Disability Rating Scale. Timepoint: 0, 1, 3 and 7 days and discharge day. Method of measurement: DRS rates eight subscales; In fact, it measures the level of consciousness, cognitive independence in self-care, employability and the need for supervision and subscale ratings, and finally gives a total score to their sum. These categories are: no disability (score 0), mild (1), partial (2-3), moderate (4-6), moderately severe (7-11), severe (12-16), very severe (17-21), vegetative state (22-24), and severe vegetative state (25-29) and death (30). DRS is scored by a neurosurgeon.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactFatemeh Saghafi

Yazd University of Medical Sciences

F.saghafi@ssu.ac.ir+98 35 3820 3419

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026